“A new procedure developed by surgeons at The University of Texas MD Anderson Cancer Center improves the accuracy of axillary staging and pathologic evaluation in clinically node-positive breast cancer, and reduces the need for a more invasive procedure with debilitating complications.
“The research, published in the Journal of Clinical Oncology, has changed treatment guidelines at the institution for a select group of breast cancer patients with lymph node metastasis, who will now receive Targeted Axillary Dissection (TAD).
“The TAD procedure involves removing sentinel lymph nodes, as well as additional cancerous lymph nodes found during diagnosis. At the time of diagnosis, those select nodes are clipped for identification during later surgery.”
“In an Italian 2×2 phase III trial reported in The Lancet, Del Mastro et al found that dose-dense adjuvant therapy with sequential epirubicin, cyclophosphamide, and paclitaxel (EC-P) with or without fluorouracil (5-FU) increased disease-free survival vs standard-interval therapy in early-stage node-positive breast cancer. No benefit of adding 5-FU to EC-P was observed.
“In this open-label trial, 2,091 patients from 81 Italian centers were randomly assigned 1:1:1:1 between April 2003 and July 2006 to receive adjuvant dose-dense chemotherapy every 2 weeks with pegfilgrastim (Neulasta) support with 5-FU plus EC-P (FEC-P, n = 500) or EC-P (n = 502) or standard-interval chemotherapy every 3 weeks with FEC-P (n = 544) or EC-P (n = 545). The primary endpoint was disease-free survival in the intention-to-treat population, with primary comparisons between every-2-week vs every-3-week schedules and FEC-P vs EC-P.
“Overall, patients had a median age of 51 to 53 years, 47% to 55% were postmenopausal, 59% to 63% had lumpectomy, 48% to 52% had T1 tumors, 57% to 64% had one to three positive nodes, 43% to 49% had grade 3 tumors, 21% to 24% were HER2-positive, 77% to 81% were estrogen or progesterone receptor–positive, and 43% to 50% had ≥ 20% Ki67-positive cells.
“The investigators concluded: ‘In patients with node-positive early breast cancer, dose-dense adjuvant chemotherapy improved disease-free survival compared with standard interval chemotherapy. Addition of fluorouracil to a sequential EC-P regimen was not associated with an improved disease-free survival outcome.’ ”
“Women with lymph node-positive breast cancer who demonstrate complete nodal response by axillary ultrasound after neoadjuvant chemotherapy may be able to avoid axillary dissection, according to study results.
“ ‘Our goal here is really to try to get away from, “Every patient with breast cancer needs these drugs and this amount of chemotherapy and surgery,” and instead to personalize surgical treatment based on how the patient responds to chemotherapy,’ Judy Boughey, MD, chair of the division of surgery research at Mayo Clinic in Rochester, Minnesota, said in a press release.
“The American College of Surgeons Oncology Group (ACOSOG) Z1071 trial included 687 patients with T0-4, N1-2, M0 primary invasive breast cancer. All patients completed neoadjuvant chemotherapy, underwent sentinel lymph node surgery and axillary dissection, and had axillary ultrasound images available for review.
“Previously published results indicated a 12.6% false-negative rate for sentinel lymph node surgery after neoadjuvant chemotherapy for patients who presented with node-positive disease and had two or more sentinel lymph nodes identified and removed. This false-negative rate exceeded the predetermined acceptable rate of 10%. The result suggested patient selection or technique must be improved prior to widespread adoption of sentinel lymph node surgery in this setting, according to study background…
“ ‘That’s one of the really nice things about giving chemotherapy up front,’ Boughey said. ‘It allows us to be less invasive with surgery, both in terms of breast surgery and lymph node surgery, and to tailor treatment based on response to chemotherapy.’ “